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Recruiting NCT06272422

Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning

— Observational Coxarthrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hip arthroplasty.
Who it may be relevant to
Registry conditions: Coxarthrosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA

Overview

The study will analyze hip biomechanical parameters using EOS radiographic measurements pre- and post-operatively (3 months) and post-operatively (3 months) CT scans after total hip replacement (THR), neck-preserving THR of the Minihip type or hip resurfacing (HR). Clinical results will be assessed at 3 months and 1 year after surgery. To this end, two types of examination are carried out, both of which are used in current practice: * Pre-operatively: EOS radiography * Post-operatively: EOS radiograph and CT scan Inclusion (m-3; m-1) : * Patient information at pre-operative visit * Non-opposition of patient, family member or legal guardian, if applicable * Questionnaires and clinical examination (standard management) * EOS during anesthetic consultation Follow-up visit (m+3): \- Post-operative follow-up consultation EOS and CT scan (1 week prior to visit) + questionnaire and clinical examination Follow-up visit (m+12): \- Post-operative check-up, questionnaire and clinical examination

Interventions

  • Procedure hip arthroplasty
    resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty.

Primary outcome measures

  • Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty. [Time frame: It will be measured using CT scans at 3 months post-op for each hip.]
Secondary outcome measures (3)
  • Compare the anatomical restoration of frontal and axial parameters between the 3 types of intervention (PTH, Minihip and RSA). [Time frame: 3 months post-op]
  • Compare clinical outcomes and patient satisfaction between the 3 procedures (PTH, Minihip and RSA). [Time frame: 3 months then 1 year post-op]
  • Correlate restoration of hip femoral offset and patient functional outcome at 3 months. [Time frame: 3 months post-op]

Eligibility criteria

Inclusion criteria

  • Male or female
  • Age ≥ 18 years
  • Planned surgery: total hip arthroplasty, Minihip or RSA
  • Absence of osteoarthritis or osteoarthritis ≤ stage 1 (Tönnis classification) of contralateral hip (Radiographic analysis)
  • Patient having given his/her non-opposition to participate in the study
  • Patient with social insurance
  • Patient willing to comply with all study procedures and duration

Exclusion criteria

  • Patient with comorbidity(ies) likely to affect biomechanical parameter measurements or surgical conditions:
  • Anomalies or anatomical changes of the hip, pelvis or lumbar spine (history of fracture, protrusion, scoliosis, history of orthopedic surgery, dysplasia, torsion disorder)
  • Established genetic disease affecting the musculoskeletal system
  • Severe or morbid obesity
  • Neuromuscular pathologies affecting the limb girdles
  • Severe osteoporosis
  • Bone location of primary or metastatic cancer (spine, pelvis or femur) - Inequality of lower limb length > 2 cm.
  • Minors
  • Protected adults
  • Pregnant or breast-feeding women
  • Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to participate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • chu de Lille — Lille

Identifiers

NCT: NCT06272422 · 2022/0472 · 2023-A00358-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗